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NDC 70165-0300-30 Cotempla XR-ODT 25.9 mg/1 Details
Cotempla XR-ODT 25.9 mg/1
Cotempla XR-ODT is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Neos Therapeutics Brands, LLC. The primary component is METHYLPHENIDATE.
MedlinePlus Drug Summary
Methylphenidate is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children. Methylphenidate (Methylin) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Methylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by changing the amounts of certain natural substances in the brain.
Related Packages: 70165-0300-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Methylphenidate
Product Information
| NDC | 70165-0300 |
|---|---|
| Product ID | 70165-300_0bdd78c5-378c-082a-e063-6294a90aedea |
| Associated GPIs | 6140002000H430 |
| GCN Sequence Number | 077496 |
| GCN Sequence Number Description | methylphenidate TAB RAP BP 25.9 MG ORAL |
| HIC3 | H2V |
| HIC3 Description | TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY |
| GCN | 43536 |
| HICL Sequence Number | 033556 |
| HICL Sequence Number Description | METHYLPHENIDATE |
| Brand/Generic | Brand |
| Proprietary Name | Cotempla XR-ODT |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Methylphenidate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, ORALLY DISINTEGRATING |
| Route | ORAL |
| Active Ingredient Strength | 25.9 |
| Active Ingredient Units | mg/1 |
| Substance Name | METHYLPHENIDATE |
| Labeler Name | Neos Therapeutics Brands, LLC |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | NDA |
| Application Number | NDA205489 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70165-0300-30 (70165030030)
| NDC Package Code | 70165-300-30 |
|---|---|
| Billing NDC | 70165030030 |
| Package | 5 BLISTER PACK in 1 CARTON (70165-300-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| Marketing Start Date | 2017-06-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 15.5924 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | COTEMPLA XR-ODT 25.9 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |